Class III · Low risk
ESTEE LAUDER DayWear Sheer Tint Release
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
FDA drug recalls in 2012
Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
534 recalls, newest first.
Class I · High risk
Ultimate Formula
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Classic Zi Xiu Tang
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Class II · Moderate risk
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Class II · Moderate risk
Necon 1/35-28
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Necon 10/11
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Zenchent (norethindrone and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Lutera (levonorgestrel and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Zovia (ethynodiol diacetate and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class III · Low risk
AcneFree Acne Pore Cleanser
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree Severe Maximum Strength Acne Pore Cleanser
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree 3-in-1 Acne Night Repair Foam
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree Acne Astringent Toner Pads
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Class III · Low risk
AcneFree Original Strength Terminator
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree Oil-Free Acne Cleanser
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class II · Moderate risk
Perphenazine Tablets
Tablet Separation: Possibility of cracked or split coating on the tablets.
Class II · Moderate risk
QUETIAPINE Fumarate Tablets 25mg 100 Tablets
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class II · Moderate risk
Arranon (nelarabine)
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Class II · Moderate risk
All Non Sterile Products manufactured by NECC
GMP Deviations
Class II · Moderate risk
All Sterile Products manufactured by NECC
Lack of Assurance of Sterility
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Class II · Moderate risk
Colloidal Silver
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.